metastatic castration-resistant prostate cancer
Conditions
Interventions
Group A:Fluzopali 150mg, bid+ all-trans retinoic acid 10mg, bid
Group B:Fluzopali 150mg, bid+ all-trans retinoic acid 20mg, bid
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years, adult males; 2.ECOG score 0~1; 3.Expected survival time is greater than 3 months; 4.Patients with clinically proven progression of mCRPC: during or after the most recent treatment before screening, they had progression according to the PCWG3 criteria, defined as one or more of the following three criteria: (1)PSA progression: elevated PSA levels with at least 2 measurement intervals >=1 week. PSA in screening period >=1 µg/L (1 ng/mL); (2)Progression of soft tissue lesions defined by RECIST 1.1; (3)Progression of bone lesion: defined as at least two new lesions found on bone scan. 5.Imaging examination with at least one lesion that can be evaluated according to RECIST 1.1 and evidence of metastatic disease: metastasis of soft tissue shown by computed tomography/magnetic resonance imaging (CT/MRI) and/or bone lesion identified by bone scan; 6.Prior treatment with abirirone acetate or a novel AR antagonist (e.g., enzaluamide, apatamine, SHR3680, etc.) and at least first-line chemotherapy failed (radiological progression or PSA progression); Patients with prior chemotherapy intolerance or rejection were allowed to be enrolled; 7.Agree to provide tumor core tissue or biopsy tissue or blood for genetic testing; 8.The functions of vital organs meet the following requirements (no use of any blood components or cell growth factor correction treatment within 14 days before the first medication): (1)NEUT>=1.5x10^9/L; (2)PLT >= 80x10^9/L; (3)Hb >= 80 g/L; (4)TBIL=160mmHg or diastolic >=95mmHg). If blood pressure can be effectively controlled through antihypertensive therapy, subjects with a history of hypertension are allowed to participate in this study; 11.Male fertile participants must agree to use appropriate contraception from the beginning of the first dose of study treatment to 120 days after the last dose of study treatment. 12.Volunteer to join the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.The elution period from the end of any previous anti-tumor therapy (including radiotherapy, chemotherapy, surgery, molecular targeted therapy, immunotherapy, first-generation androgen receptor antagonists, 5-reductase inhibitors, estrogen, progesterone drugs, etc.) to the first administration of this study was less than 4 weeks (except the elution period of bicaluramide = 500 IU/ml; Hepatitis C reference: positive HCV antibody and HCV virus copy number > the upper limit of normal value); 9.Suffering from untreated central nervous system metastatic disease; 10.Suffered from other malignancies within 5 years before the first dose of the study (except for carcinoma in situ with complete remission and malignancies determined by the investigator to have progressed slowly); 11.History of immunodeficiency (including HIV positive, other acquired or congenital immunodeficiency diseases) or organ transplantation; 12.Allergy to the ingredients or excipients in fluzoparib and all-transretinoic acid; 13.Have previously received fluzoparib or any other PARP inhibitor or all-transretinoic acid; 14.Currently receiving strong or moderate inhibitors of cytochrome P450 (CYP3A4), and should not be discontinued during the study period; 15.Have received previous allogeneic bone marrow transplantation or double umbilical cord transplantation (dUCBT) or solid organ transplantation; 16.Binge drinking or regular alcohol consumption in the 6 months prior to the screening period, i.e. consumption of more than 14 units of alcohol per week (1 unit =360 ml beer or 45 ml 40% spirits or 150 ml wine); Those who smoked more than 10 cigarettes per day or habitually used nicotine-containing products within 3 months prior to the screening period and could not quit during the test period; Habitually consuming grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages and unable to quit during the study period; 17.A history of (non-infectious) pneumonia requiring steroid treatment, or current pneumonia; 18.Suffering from congenital or acquired immune function defects (e.g. HIV infected); 19.Get live vaccines within 30 days before screening; 20.According to the judgment of the investigator, there are any accompanying diseases (such as severe diabetes, thyroid disease, mental illness, etc.) that seriously endanger the safety of the patient or affect t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of remission;Disease control rate;Progression-free survival assessed by imaging;Safety;To remission time;Survival rate;Duration of prostate-specific antigen remission;Adverse event;Serious adverse event; | — |
Countries
China
Contacts
Public ContactHuang Hai
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed